HGH

Somatotropic Hormone Compounds (STH)

HOW TO USE THE PRODUCT:

Each kit contains 10 vials of Somatropin HGH and 10 bottles of mixing solution.

Each Somatropin vial has 3.33 mgs. Each kit has a total of 100 I.U.

Add a supplied bottle of mixing solution to a vial containing the SOMATROPIN using a mixing syringe (not supplied). Gently dissolve the drug with a slow, swirling motion. Do not shake vigorously, or the active ingredient might lose its effectiveness. Keep this reconstituted vial in cold temperature (2 - 8 degrees Celsius) for the duration of its use.:

QUALITATIVE AND QUANTITATIVE COMPOSITION OF ACTIVE INGREDIENT

Powder for injection substance 10 IU One vial contains Powder for injection of (rDNA origin) 10 IU.

PHARMACEUTICAL FORM

Powder for injection prepared with supplied solvent, with or without preservative, for subcutaneous (s.c.) administration.

PHARMACO-THERAPEUTIC GROUP

SOMATROPIN stimulates linear growth and increases growth rate in children who lack adequate endogenous growth hormone. In adults with growth hormone deficiency, SOMATROPIN reduces fat mass, increases muscle mass and improves energy, vitality and subjective well-being. In patients suffering from severe burns, AIDS associated muscle wasting, or undergoing major operations, SOMATROPIN promotes wound healing, attenuates the protein-catabolic response and improves whole-body nitrogen economy after operation.

HOLDER OF THE AUTHORIZATION

SOMATROPIN is manufactured by GeneScience Pharmaceuticals Co., LTD, Changchun, China. It is the largest biotech company in China and further information can be obtained from the local GeneScience offices in the different Member States.

THERAPEUTIC INDICATIONS

Growth disturbance due to insufficient secretion of growth hormone or associated with gonadal dysgenesis or Turner¡¯s syndrome which is a chromosome aberration.

Growth disturbance in prepubertal children with chronic renal insufficiency. Replacement therapy in adults with pronounced growth hormone deficiency. Promote wound healing and attenuate catabolic responses in severe burns, sepsis, multiple trauma, major operations, acute pancreatitis and intestinal fistula.

Topical application to promote wound healing in acute wound or chronic ulcer, such as burns, diabetic foot ulcer, chronic venous ulcer and decubital ulcer.

CONTRAINDICATIONS

SOMATROPIN should not be used when there is any evidence of activity of brain tumor. Intracranial lesions must be inactive and antitumour therapy completed prior to starting therapy.

SOMATROPIN should not be used for growth promotion in children with closed epiphyses.

WARNINGS AND PRECAUTIONS

The diagnosis should be confirmed before treatment starts. Therapy with Somatropin should be directed by suitably qualified physicians. In diabetes mellitus, the dose of insulin might require adjustment by your physician before SOMATROPIN treatment starts.

Experience in adult GHD patients above 60 years is lacking. Experience with prolonged treatment in adults is limited. In chronic renal insufficiency the renal function should be investigated before start of the treatment. The treatment should be discontinued after renal transplantation.

PREGNANCY AND LACTATION

No clinical experience of the use in pregnant women is available. Treatment with SOMATROPIN should be interrupted if pregnancy occurs. Information is lacking whether peptide hormones pass over into the breast milk but absorption in the gastro-intestinal tract of the infant of intact protein is extremely unlikely.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

The ability to react is not influenced by Somatropin.

DOSAGE AND ADMINISTRATION

- The dosage is individual, based on body weight or body surfaces area and should be determined by your physician.

- Growth disturbance due to insufficient secretion of growth hormone in children: Generally a dose of 0.5-0.7 IU/kg/wk or 14-20 IU/m2/wk is recommended. Even higher doses have been used.

- Gonadal dysgenesis (Turner's syndrome): A dose of 1.0 IU/kg/wk or 28 IU/m2/wk is recommended.

- Chronic renal insufficiency: A dose of 30IU/m2/wk (approximately 1 IU/kg/wk) is recommended.

- Higher doses can be needed if growth velocity is too slow. A dose correction can be needed after six months of treatment.

- Growth hormone deficiency in adults: An initial dose for about four weeks of 0.125 IU/kg/wk, is recommended. The daily dose should then be modulated according to the side effects of the patients as well as determination of Insulin like Growth Factor-l (IGF-I) in serum as guidance.
- The weekly dose should be divided into 7 s.c. injections.
- The injection site should be varied to prevent lipoathrophy.
- If treatment has been forgotten one day do not take double doses the next day but continue the treatment according to the directions.
- For severe burns or multiple injuries, it is recommended an initial dose of 8IU/day followed by 16IU/day after patients' blood glucose level is stabilized. Typical treatment starts in 6 days after burns or injuries and treatment length is about 15-20 days.

- For major operations, 12IU/day for a period of 10 days is recommended. Typical treatment starts in 2-3 days after operations.

- For topical application to wound or ulcer surface, a dose of 0.2IU/cm2 is recommended at three times a day. Length of treatment depends on healing time.

OVERDOSAGE

No overdose or intoxication is known. If an overdose of SOMATROPIN has been injected contact should be taken with your physician.

ADVERSE REACTIONS

- Side effects have been noted in approximately 10% (most common local skin reactions) of the patients participating in clinical trials in children with short stature.

In clinical trials in adults side effects have been noted in approximately 30 to 40% of the patients, primarily related to symptoms of fluid retention (oedema). These events have an early onset after initiation of therapy, but with a reduction in incidence and prevalence over time and rarely influencing daily activities.

- SOMATROPIN has given rise to the formation of antibodies in very few patients. This has no influence on the treatment result.

- It has been reported that patients may develop hypothyroidism during treatment with SOMATROPIN which should be considered by your physician.

- If nausea and/or vomiting, severe and recurrent headache especially in combination with visual problems occur take contact with your physician.

INCOMPATIBILITIES

Incompatibilities have not been reported for combined use of SOMATROPIN with other medicaments or medical solution.

SHELF LIFE

The powder for injection is assigned a shelf life of 24 months when stored cold at +2 to +8°.

Storage for one month can take place in room temperature.
Reconstituted SOMATROPIN with preservative may be stored cold at +2 to +8° for 2 weeks protected from light.

SPECIAL PRECAUTIONS FOR STORAGE

Frozen powder should not be used. Store cold at +2 to +8°.

INSTRUCTIONS FOR USE/HANDLING

Vials: add solvent to vial with powder for injection. Gently dissolve the drug with a slow, swirling motion. Do not shake vigorously, or the active ingredient might denature.